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Drug ReportsMidazolam maleate
Midazolam maleate
Buccolam, Midazolam, Midozalam, Nayzilam, Seizalam (midazolam maleate) is a small molecule pharmaceutical. Midazolam maleate was first approved as Versed on 1985-12-20. It is used to treat anxiety disorders, psychomotor agitation, and status epilepticus in the USA. It has been approved in Europe to treat epilepsy.
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
nervous system diseasesD009422
signs and symptoms pathological conditionsD013568
behavior and behavior mechanismsD001520
mental disordersD001523
Trade Name
FDA
EMA
No data
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
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Labels
FDA
EMA
Brand Name
Status
Last Update
seizalamNew Drug Application2023-01-26
versed guards up daily mineral sunscreen broad spectrum spf 35OTC monograph final2022-08-30
versed spf 30 replenishing body mineralC2002632024-12-20
Indications
FDA
EMA
No data
Agency Specific
FDA
EMA
Expiration
Code
MIDAZOLAM, NAYZILAM, UCB INC
2026-05-17ODE-243
MIDAZOLAM HYDROCHLORIDE, SEIZALAM, MMT
2025-09-14ODE-207
Patent Expiration
Patent
Expires
Flag
FDA Information
Midazolam, Midazolam In 0.9% Sodium Chloride, Inforlife
109669902038-06-20DP
Midazolam, Nayzilam, Ucb Inc
82170332028-01-18DPU-2526
88093222028-01-18DP
92894322028-01-18DPU-2526
96874952028-01-18DPU-2526
ATC Codes
N: Nervous system drugs
— N05: Psycholeptics
— N05C: Hypnotics and sedatives
— N05CD: Benzodiazepine derivative hypnotics and sedatives
— N05CD08: Midazolam
HCPCS
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Clinical
Clinical Trials
1628 clinical trials
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Indications Phases 4
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Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
SeizuresD012640—G40.4——5——5
EpilepsyD004827EFO_0000474G40.9——4——4
Indications Phases 2
No data
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Healthy volunteers/patients———2————2
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameMidazolam maleate
INNmidazolam
Description
Midazolam is an imidazobenzodiazepine that is 4H-imidazo[1,5-a][1,4]benzodiazepine which is substituted by a methyl, 2-fluorophenyl and chloro groups at positions 1, 6 and 8, respectively. It has a role as a GABAA receptor agonist, an anticonvulsant, an anxiolytic drug, an apoptosis inducer, an antineoplastic agent, a muscle relaxant, a sedative, a general anaesthetic and a central nervous system depressant. It is an organochlorine compound, an imidazobenzodiazepine and a member of monofluorobenzenes.
Classification
Small molecule
Drug classBenzodiazepine
Image (chem structure or protein)Loading
Structure (InChI/SMILES or Protein Sequence)
Cc1ncc2n1-c1ccc(Cl)cc1C(c1ccccc1F)=NC2.O=C(O)/C=C\C(=O)O
Identifiers
PDB—
CAS-ID59467-70-8
RxCUI6960
ChEMBL IDCHEMBL2106922
ChEBI ID—
PubChem CID4192
DrugBankDB00683
UNII IDR60L0SM5BC (ChemIDplus, GSRS)
Target
No data
Variants
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 16,670 documents
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Safety
Black-box Warning
Black-box warning for: Seizalam
Adverse Events
Top Adverse Reactions
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1,253 adverse events reported
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